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RecruitingPHASE3INTERVENTIONAL

A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

This study aims to see if a new medicine, nerandomilast, can help slow down early changes in the lungs for people who have a family history of pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. If you are aged 40 or over and have a close family member (parent, sibling, or child) with pulmonary fibrosis, and a lung scan shows early changes, you might be able to join. Some participants will receive nerandomilast tablets, and others will receive a placebo (dummy pill). The study involves taking a tablet twice a day for 2 to 3 years, with regular visits and tests to monitor lung health and check for any effects.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Boehringer Ingelheim
Enrolment target
80
Start
10 Feb 2026
Estimated completion
23 May 2029

What is this study about?

This research study is looking into a condition called pulmonary fibrosis, where the lungs become scarred over time, making it difficult to breathe. We know that if a close family member has pulmonary fibrosis, there's a higher chance of other family members developing it too. Sometimes, doctors can spot early changes in the lungs through special scans even before symptoms become severe, which are called interstitial lung abnormalities.

This study is trying to find out if a new medicine, called nerandomilast, can help slow down these early lung changes in people with a family history of pulmonary fibrosis. By taking part, you'd be helping doctors understand if this medicine could prevent or slow down the progression of lung scarring, potentially benefiting those at risk in the future.

Participants will be placed into one of two groups by chance: one group will take the study drug, nerandomilast, and the other will take a placebo, which looks identical but contains no active medicine. This allows doctors to compare the effects of the drug against not having it, to see if it truly makes a difference. Doctors will carefully monitor everyone's lung health throughout the study.

Key takeaways

  • The study is investigating a new drug (nerandomilast) for early lung changes.
  • It's for people aged 40+ with a close family member who has pulmonary fibrosis.
  • Participants will receive either the drug or a dummy pill (placebo) for 2-3 years.
  • Regular clinic visits and lung tests will monitor your health.
  • Your participation helps doctors understand if the drug can prevent or slow lung scarring.
  • You have a 3 in 5 chance of receiving the active drug.

Who may be eligible?

This study is for adults aged 40 years or older. You must have at least one close family member (like a parent, sibling, or child) who has been diagnosed with pulmonary fibrosis or other related lung scarring conditions. Importantly, a special lung scan (HRCT) must show early changes in your lungs, known as interstitial lung abnormalities, which cover at least 5% of a single lung section.

There are also some criteria that would mean you couldn't join. For example, if you already have a diagnosed lung scarring condition that needs treatment, or if your lung function tests fall below certain levels. Also, if you have other conditions known to cause lung scarring, such as certain connective tissue diseases, or if you've previously taken nerandomilast or other specific lung fibrosis medicines, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 40 years old or older?
  2. Do you have a parent, sibling, or child with confirmed pulmonary fibrosis?
  3. Have you had a lung scan (HRCT) showing early lung changes (interstitial lung abnormalities)?
  4. Are your breathing test results (FVC and DLCO) within specific healthy ranges?
  5. Do you *not* currently need treatment for existing pulmonary fibrosis?
  6. Have you *not* previously taken nerandomilast, nintedanib, or pirfenidone?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be in the study for about 2 to 3 years. You'll be asked to take a tablet twice a day – either the study drug, nerandomilast, or a placebo (dummy pill). There's a 3 out of 5 chance you'll receive nerandomilast. You won't know which one you're taking, and neither will your local study team.

Over the study period, you'll have several visits to the study clinic. In the first two years, these visits will be more frequent, happening about every three months. After that, they'll be every six months. In the third year, you'll also have phone conversations with the study team every three months to check in on how you're doing. During these visits, doctors will regularly check your lung function with breathing tests and take chest scans to see if the treatment is having an effect. They will also keep a close eye on your general health and any side effects you might experience.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new investigational treatment for a condition you're at risk of developing, and meticulous monitoring of your lung health. However, there are potential risks, including side effects from the study drug, which may or may not be known. The placebo group will not receive the active drug. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (56)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of California Los Angeles
    Verified postcode
    Los Angeles, United States· Not yet recruiting
  • University of Colorado Denver
    Verified postcode
    Aurora, United States· Not yet recruiting
  • Clinical Research Specialists LLC - Kissimmee
    Verified postcode
    Kissimmee, United States· Not yet recruiting
  • University of Kansas Medical Center
    Verified postcode
    Kansas City, United States· Not yet recruiting
  • Brigham and Women's Hospital
    Verified postcode
    Boston, United States· Recruiting
  • University of Michigan
    Verified postcode
    Ann Arbor, United States· Not yet recruiting
  • University of Minnesota
    Verified postcode
    Minneapolis, United States· Not yet recruiting
  • Weill Cornell Medicine-New York-60569
    Verified postcode
    New York, United States· Not yet recruiting
  • University of Pennsylvania
    Verified postcode
    Philadelphia, United States· Not yet recruiting
  • Medical University of South Carolina
    Verified postcode
    Charleston, United States· Not yet recruiting
  • Vanderbilt University Medical Center
    Verified postcode
    Nashville, United States· Not yet recruiting
  • Baylor College of Medicine
    Verified postcode
    Houston, United States· Not yet recruiting

Common questions

What is pulmonary fibrosis?

Pulmonary fibrosis is a lung condition where the tissue in the lungs becomes scarred over time, making them stiff and less able to take in oxygen, which can make breathing difficult.

What does 'family history' of pulmonary fibrosis mean for this study?

It means you have a close blood relative – a parent, sibling, or child – who has been diagnosed with pulmonary fibrosis or a similar lung scarring condition.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It helps researchers compare the effects of the real drug.

How often will I need to visit the clinic?

During the first two years, you'll visit the clinic about every three months. After that, it will be every six months, with additional phone calls in the third year.

Will I know if I'm taking the study drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study doctors will know whether you are receiving nerandomilast or the placebo. This helps get accurate results.

How to find out more

Boehringer Ingelheim

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Test Whether Nerandomilast Can Help Slow Down Cha…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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